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临床试验/NCT06933342
NCT06933342招募中不适用

Evaluating an Integrated Habituation Programme for Enhancing Dental Examination Acceptance in Children With Autism Spectrum Disorder: An Effectiveness Trial

Oral Health Center of Expertise Rogaland, Norway2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
225
试验地点
2
主要终点
Completion of a clinical dental examination with good cooperation

研究概览

简要总结

The goal of this effectiveness trial is to investigate if an integrated dental habituation programme can enhance acceptance of a clinical dental examination in children (aged 5-8 years) with autism spectrum disorder (ASD).

The main questions it aims to answer are:

  • Can a dental habituation programme performed by trained dental hygienists increase the acceptance of a clinical dental examination in children with ASD?
  • Is a dental habituation programme for children with ASD more effective compared to home preparation using visual aids performed by parents/guardians in increasing the acceptance of a clinical dental examination in children with ASD?

The study participants will be randomly assigned to either the habituation group (intervention) or the home preparation group (augmented control) to investigate the effectiveness in increasing acceptance and cooperation of a clinical dental examination.

详细描述

BACKGROUND Autism Spectrum Disorder (ASD) is a developmental disorder characterized by deviations in language, communication, social interaction, and a restricted and repetitive pattern of activities and interests. Good oral health is crucial for life satisfaction and impacts general health, nutrition, appearance, and communication. Several studies have shown that children with ASD often face challenges during oral examinations and dental treatments. Increased stress and anxiety in these patients also make dental treatment challenging for caregivers and the dental team. Various studies have demonstrated that communication aids, such as visual tools (pictures, books, films), and familiarization techniques (e.g., tell-show-do), can reduce stress and increase cooperation during dental examinations. Studies indicate that knowledge about ASD among healthcare professionals is limited. Despite continuous improvements, there is significant variation in knowledge levels across different age groups and professional backgrounds. A lack of knowledge and confidence in their skills among healthcare professionals can result in poorer healthcare services for children with ASD. Sufficient knowledge and early intervention are essential for achieving positive outcomes for this patient group.

METHODS

Design and Procedures:

To address this challenge and enable more dental examinations at local clinics, the investigators have developed a training program for dental personnel. The course, developed by pediatric dentists, was presented to a resource group consisting of a psychologist, a dental hygienist, dentists, a researcher, and a parent of a child with ASD. Adaptations were made based on feedback from the resource group. The course includes both theoretical and practical content, focusing on ASD characteristics, communication techniques, and tools specific to this patient group to increase cooperation and the completion of clinical dental examinations. During the course, dental personnel will be trained in a habituation program to provide a gradual and structured approach to dental examinations, minimizing unwanted behavior and reducing perceived stress in the child, parent, and dental practitioner. To the effectiveness of the integrated habituation program will be evaluated in a randomized controlled trial. The intervention will last for 5 weeks, with one habituation session each week. The habituation sessions will be performed at selected dental clinics. Clinics will be selected based on geographical location, and on the affiliation of the dental hygienist participating in the study.

Participants will be recruited from two counties in western Norway (Rogaland and Vestland) and randomly assigned to either the intervention group or an augmented control group. The augmented control group will receive a toolbox with visual aids for home preparation before a dental appointment, similar to the intervention group. Participation will be based on written informed consent provided by the parents og caregivers of the children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

To investigate the effectiveness of the intervention (the habituation program), blinded dental personell (not part of the study otherwise) will perform an oral examination (treatment as usual) on the children approx. 6 weeks following the first habituation/starting preparation at home.

入排标准

年龄范围
5 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children living in the counties Rogaland or Vestland, Norway
  • •English or Norwegian speaking
  • •Have not been able to complete a clinical dental examination at the local dental clinic
  • •Has an autism spectrum diagnosis (reported by parents/guardians)

排除标准

  • •Children not living in the counties Rogaland or Vestland, Norway
  • •Does not speak English or Norwegian
  • •Have completed a dental examination at the local dental clinic
  • •Have other severe developmental cognitive disabilites (in addition to an autism spectrum diagnosis) (reported by parents/guardians)

研究组 & 干预措施

At home preparation

Other

The control group will be an augmented control group. The participants in this group will receive a "toolbox" with visual aids and a dental examination mirror and written instructions on how to use the toolbox for preparations at home prior to the dental appointment

干预措施: Preparations at home (Behavioral)

Habituation group

Experimental

Participants in the experimental group will receive five structured habituation sessions in a dental clinic with a trained dental hygienist. Parents/guardians will receive a "toolbox" with visual aids, a dental examination mirror and instructions for use at home preparations prior to the habituation sessions.

干预措施: Habituation to dental examination (Behavioral)

结局指标

主要结局

Completion of a clinical dental examination with good cooperation

时间窗: 6 weeks after the first habituation session/home preparation

The dental examination has been divided into several steps (i.e., sitting in the chair, accepting examination with dental mirror, accepting light from the lamp, examination with probe). The primary objective will be completion of a clinical dental examination (examination with mirror and probe) with good cooperation. After 5 weeks (either with home preparation or habituation sessions) a blinded dental personell (untrained) will do a clinical dental examination (treatment as usual). Cooperation will be measured using the Frankl scale, reported by the parents/guardians for each step in the dental examination.

次要结局

  • Changes in child stress measured by Wong-Baker FACES pain rating scale(At session 1, (only intervention group), after 6 weeks (intervention and control group))
  • Changes in cooperation assessed by Frankl scale(Once per week for 5 weeks)

研究者

发起方
Oral Health Center of Expertise Rogaland, Norway
申办方类型
Other
责任方
Sponsor

研究点 (2)

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